Table 1

European Public Assessment Report summary paper version: original (round 1) and revised (round 2)

Original (round 1)Revised (round 2)
QuestionsNumber of points found/understoodTarget met?Number of points found/understoodTarget met?
1  Who has this report been written for?  7 / 7No  8 / 8No
2  When is Bondronat used in breast cancer?  9 / 4No  10 / 7No
3  What is the purpose of this report?  7 / 0No  9 / 9Yes
4  What can the tablets do to the food pipe?  10 / 0No  10 / 10Yes
5  Who made the decision about Bondronat described in this report?  10 / 1No  9 / 9Yes
6  What group of medicines does Bondronat belong to?  7 / 7No  10 / 10Yes
7  What did Committee for Medicinal Products for Human Use (CHMP) decide about Bondronat?  10 / 10Yes  10 / 10Yes
8  The tablets can irritate the food pipe. Which people cannot have the tablets as a result of this?  9 / 8Yes  10 / 8No
9  What two things were weighed up before decision made about whether Bondronat should be approved?  7 / 7No  10 / 10Yes
10  How does Bondronat prevent fractures, or broken bones?  10 / 9Yes  8 / 7No
11  In the studies looking into bone problems or complications, what was looked at to see if Bondronat was working?  5 / 4No  10 / 9Yes
12  During the studies into high calcium levels, how many people did the 4 mg dose work in?  9 / 9Yes  10 / 10Yes
13  How many people receiving a Bondronat infusion got a fever?  10 / 3No  10 / 8No
14  During the study of bone complications, what was Bondronat compared with?  9 / 9Yes  10 / 10Yes
15  Suppose you want more information on how the decision was made about Bondronat, what should you do?  9 / 1No  10 / 9Yes
16  How many people taking the Bondronat tablet got an inflamed food pipe?  10 / 5No  10 / 9Yes
17  In the research studies of high calcium levels in the blood, what was Bondronat compared against?  9 / 9Yes  9 / 9Yes
18  When Bondronat was studied in the treatment of bone complications, which group of patients got a new bone problem first?  8 / 8No  9 / 9Yes
19  If you are a patient and want more information about Bondronat, what should you do?  8 / 7No  10 / 10Yes
  Total number of passes614